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Comparison of Femoral Nerve Block Versus Fascia Iliaca Compartment Block for Pain Control in Traumatic Femur Fracture Repair in Pediatric Population

Primary Purpose

Regional Anesthesia Morbidity

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fascia Iliaca compartment block group
Femoral nerve block group
General care
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Regional Anesthesia Morbidity

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients are within the age range of 5 to 12 years old. Isolated Traumatic fracture of the femur bone. ASA I or II physical status. Pts weighed ≥10 kg Exclusion Criteria: Refusal of the patient's parents or legal guardians to give informed consent. History of allergy to any of the study drugs. Injury at the site of injection. Vascular compromise an injured leg. Bilateral femur fracture. Recent trauma to the head, chest, or abdomen. history of bleeding disorder, or anticoagulant therapy. Preoperative intake of opioid or non-steroidal anti-inflammatory drugs within 24 h before surgery. Neurological and/or psychological diseases. Associated cardio-respiratory illness.

Sites / Locations

  • Menoufia university hospitailsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control group

Group FICB

Group FNB

Arm Description

Control group

✓ Group FICB; (30 patients) Fascia Iliaca compartment block group.

✓ Group FNB; (30 patients) Femoral nerve block group.

Outcomes

Primary Outcome Measures

Postoperative pain
Assessing the Postoperative pain using The Face, Legs, Activity, Cry and Consolability (FLACC) scale.

Secondary Outcome Measures

Postoperative need for analgesia
Postoperative need for analgesia using The visual analog scale (VAS) to evaluate the pain

Full Information

First Posted
April 4, 2023
Last Updated
May 21, 2023
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05882201
Brief Title
Comparison of Femoral Nerve Block Versus Fascia Iliaca Compartment Block for Pain Control in Traumatic Femur Fracture Repair in Pediatric Population
Official Title
Comparison of Femoral Nerve Block Versus Fascia Iliaca Compartment Block for Pain Control in Traumatic Femur Fracture Repair in Pediatric Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pediatric orthopedic surgical procedures require a multimodal approach for anesthetic management that maximizes both patient comfort and safety. (1) A multimodal strategy for perioperative pain management is often required for children undergoing orthopedic surgery including pharmacological methods, and regional anesthesia (R.A). (1,2) Recent guidelines published jointly by the European Society of Regional Anesthesia (ESRA) and the American Society of Regional Anesthesia (ASRA) recommend that regional blocks can and should preferably be performed under general anesthesia or deep sedation in children of all ages. (3,4) Many studies investigated the safety of regional pediatric nerve blocks These studies showed pediatric complication rates consistent with adult data. These complications include nerve injury, intravascular injection and local anesthetics systemic toxicity (LAST), and acute compartmental syndrome. these complications have been minimized by ultrasound-guided nerve block in pediatrics. (5) The annual incidence of pediatric femoral fractures is estimated to be 19 per 100,000. Femoral fractures are usually associated with other injuries such as intracranial hemorrhages, lung contusions, hemothorax or pneumothorax, and other organ injuries which make regional anesthesia (R.A) is preferable as a sole technique or combined with general anesthesia to decrease the overall dosage of anesthetics and opioids. (6) The most tangible advantage of RA is profound and prolonged pain relief. Alternatively, pain relief can be given by opioids which are known to cause nausea, vomiting, respiratory depression, decrease in gut motility and increase apneic spells in the population vulnerable to the same. Nonsteroidal anti- inflammatory drugs can affect the immature renal system adversely. RA offers pain relief without changing the physiological milieu. (7) Fascia iliaca Compartment Block (FICB) has been widely used for postoperative analgesia in patients undergoing hip, femoral bone, and knee surgical procedures. FICB was first introduced by Dalens et al in 1989. This regional plane block technique was used to block the femoral nerve and the lateral femoral cutaneous nerve of the thigh and the obturator nerve with a high level of safety and success, well-suited for the anterolateral surgeries of the thigh. (8,9) Femoral nerve block (FNB) has been widely used for postoperative analgesia in patients undergoing hip, and femoral bone surgical procedures, it provides anesthesia and analgesia for the lateral aspect of the thigh and the femur bone. (10,11) FICB has a wider range of anesthesia and analgesia in lower limbs compared to FNB. but the use of dilute injectate in FICB may minimize sensory and motor block than FNB. (1,16) This study will be conducted to evaluate the effects of FICB vs FNB in pain control in pediatrics undergoing femoral fracture repair surgery.
Detailed Description
Pediatric orthopedic surgical procedures require a multimodal approach for anesthetic management that maximizes both patient comfort and safety. (1) A multimodal strategy for perioperative pain management is often required for children undergoing orthopedic surgery including pharmacological methods, and regional anesthesia (R.A). (1,2) Recent guidelines published jointly by the European Society of Regional Anesthesia (ESRA) and the American Society of Regional Anesthesia (ASRA) recommend that regional blocks can and should preferably be performed under general anesthesia or deep sedation in children of all ages. (3,4) Many studies investigated the safety of regional pediatric nerve blocks These studies showed pediatric complication rates consistent with adult data. These complications include nerve injury, intravascular injection and local anesthetics systemic toxicity (LAST), and acute compartmental syndrome. these complications have been minimized by ultrasound-guided nerve block in pediatrics. (5) The annual incidence of pediatric femoral fractures is estimated to be 19 per 100,000. Femoral fractures are usually associated with other injuries such as intracranial hemorrhages, lung contusions, hemothorax or pneumothorax, and other organ injuries which make regional anesthesia (R.A) is preferable as a sole technique or combined with general anesthesia to decrease the overall dosage of anesthetics and opioids. (6) The most tangible advantage of RA is profound and prolonged pain relief. Alternatively, pain relief can be given by opioids which are known to cause nausea, vomiting, respiratory depression, decrease in gut motility and increase apneic spells in the population vulnerable to the same. Nonsteroidal anti- inflammatory drugs can affect the immature renal system adversely. RA offers pain relief without changing the physiological milieu. (7) Fascia iliaca Compartment Block (FICB) has been widely used for postoperative analgesia in patients undergoing hip, femoral bone, and knee surgical procedures. FICB was first introduced by Dalens et al in 1989. This regional plane block technique was used to block the femoral nerve and the lateral femoral cutaneous nerve of the thigh and the obturator nerve with a high level of safety and success, well-suited for the anterolateral surgeries of the thigh. (8,9) Femoral nerve block (FNB) has been widely used for postoperative analgesia in patients undergoing hip, and femoral bone surgical procedures, it provides anesthesia and analgesia for the lateral aspect of the thigh and the femur bone. (10,11) FICB has a wider range of anesthesia and analgesia in lower limbs compared to FNB. but the use of dilute injectate in FICB may minimize sensory and motor block than FNB. (1,16) This study will be conducted to evaluate the effects of FICB vs FNB in pain control in pediatrics undergoing femoral fracture repair surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia Morbidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be a prospective randomized controlled study. Patients will be randomized by a computer-generated program into 3 equal parallel groups that will be randomly assigned to either: Control group;(30 patient). Group FICB; (30 patients) Fascia Iliaca compartment block group. Group FNB; (30 patients) Femoral nerve block group.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group
Arm Title
Group FICB
Arm Type
Experimental
Arm Description
✓ Group FICB; (30 patients) Fascia Iliaca compartment block group.
Arm Title
Group FNB
Arm Type
Experimental
Arm Description
✓ Group FNB; (30 patients) Femoral nerve block group.
Intervention Type
Procedure
Intervention Name(s)
Fascia Iliaca compartment block group
Intervention Description
Group FICB Fascia: with the patient supine, the skin was prepped and draped with alcohol solution 70%, . A 22-G needle will be visualized entering the fascia Lata and the FI. bupivacaine, up to 2.5mg/kg of lean body weight with a volume of injectate of .5 ml/kg up to 40 ml will be injected after aspiration beneath the fascia Lata.
Intervention Type
Procedure
Intervention Name(s)
Femoral nerve block group
Intervention Description
✓ Group FNB; With the patient supine, the skin will be prepped and draped with alcohol solution 70% The nerve in the crosssection is a triangular white structure lateral to the femoral artery. Ultrasoundallows direct visualization of the needle and nerve as well as real-time monitoring of the injection of local anesthetic. An in-plane approach will be used to direct needle placement to the femoral nerve and inject after aspiration with bupivacaine, up to 2.5mg/kg of lean body weight with a volume of injectate of .5 ml/kg up to 40ml.
Intervention Type
Procedure
Intervention Name(s)
General care
Intervention Description
using ordinary technique
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Assessing the Postoperative pain using The Face, Legs, Activity, Cry and Consolability (FLACC) scale.
Time Frame
expected within 6 months
Secondary Outcome Measure Information:
Title
Postoperative need for analgesia
Description
Postoperative need for analgesia using The visual analog scale (VAS) to evaluate the pain
Time Frame
expected within 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients are within the age range of 5 to 12 years old. Isolated Traumatic fracture of the femur bone. ASA I or II physical status. Pts weighed ≥10 kg Exclusion Criteria: Refusal of the patient's parents or legal guardians to give informed consent. History of allergy to any of the study drugs. Injury at the site of injection. Vascular compromise an injured leg. Bilateral femur fracture. Recent trauma to the head, chest, or abdomen. history of bleeding disorder, or anticoagulant therapy. Preoperative intake of opioid or non-steroidal anti-inflammatory drugs within 24 h before surgery. Neurological and/or psychological diseases. Associated cardio-respiratory illness.
Facility Information:
Facility Name
Menoufia university hospitails
City
Shibīn Al Kawm
State/Province
Menoufya
ZIP/Postal Code
32111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahdy Elghanam, resident
Phone
+201019593180
Email
mahdyelghanam@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31779838
Citation
Wu JP. Pediatric Anesthesia Concerns and Management for Orthopedic Procedures. Pediatr Clin North Am. 2020 Feb;67(1):71-84. doi: 10.1016/j.pcl.2019.09.006.
Results Reference
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Learn more about this trial

Comparison of Femoral Nerve Block Versus Fascia Iliaca Compartment Block for Pain Control in Traumatic Femur Fracture Repair in Pediatric Population

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